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Inventiva Piper Sandler 37th Annual Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Piper Sandler 37th Annual Healthcare Conference summary3 Dec, 2025
Key objectives and recent progress
Successfully completed fundraising, strengthening the balance sheet and enabling key 2026 objectives.
Fully enrolled phase 3 NATIVE3 trial for lanifibranor in MASH, with data readout expected in the second half of next year.
Expanded management team with experienced leaders in regulatory and clinical development.
Preparing for market entry as a third oral therapy for MASH, targeting F2 and F3 patients.
Planning a compensated F4 cirrhosis study to accelerate outcome accrual for regulatory approval.
Clinical development and study design
NATIVE3 is a surrogate approval study using histology as the primary endpoint, with outcome studies required post-approval.
Study includes a higher proportion of diabetics and F3 patients, aligning with real-world MASH demographics.
Co-primary endpoint design minimizes placebo response and demonstrates dual benefit in NASH and fibrosis.
Biopsy reading uses a consensus method, with rigorous blinding and quality control processes.
AI-based histology assessment included as an add-on, not for primary endpoint.
Competitive landscape and positioning
Lanifibranor expected to be the third agent in the MASH market after Rezdiffra and semaglutide.
Positioned for F2/F3 patients, with strong antidiabetic and antifibrotic effects, and potential for combination with GLP-1s.
Effect size in phase 2b was 18% after six months, compared to Rezdiffra's 12% after 12 months.
Commercial success anticipated if phase 3 reproduces phase 2b results, especially in diabetic subpopulations.
Market creation and awareness are increasing, with a 70% rise in diagnosed F2/F3 patients under care over four years.
Target specialist strategy for launch
Fibrosis effect needed for market leadership
Is F4 cirrhosis study needed for F2/F3 approval?
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Next Inventiva earnings date
44th Annual J.P. Morgan Healthcare Conference14 Jan, 2026
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Frequently asked questions
Inventiva S.A. is a clinical-stage biopharmaceutical company focused on the development of orally administered small molecule therapies for the treatment of serious diseases. The company's research primarily targets conditions related to fibrosis, lysosomal storage disorders, and oncology. Inventiva leverages its proprietary technology platform to identify and develop novel compounds that modulate nuclear receptors, transcription factors, and epigenetic regulation. The company's lead products are developed through strategic collaborations with other pharmaceutical companies, aiming to advance these therapies through clinical trials and regulatory approval. The company is headquartered in Daix, France, and its shares are listed on the Nasdaq.
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